BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16382661 · Received February 15, 2023

    Report

    Report Number
    1221359-2023-00338
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 11, 2023
    Report Date
    April 26, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 192377 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 / LOT 192377 AND DEVICE PART NUMBER 195-430H/ LOT 187557. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 192377 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT : SINGLE USE DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS ON FOUR (4) SEPARATE PATIENTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR REPORT IS FOR TEST TWO (2) OF FOUR (4). THE PATIENT PERFORMED AN ADDITIONAL TEST ON THE SAME DAY WITH A DIFFERENT BRAND (IHEALTH COVID-19 ANTIGEN RAPID TEST) AND TESTED POSITIVE WITH THIS BRAND. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS ON FOUR (4) SEPARATE PATIENTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023. THIS MFR REPORT IS FOR TEST TWO (2) OF FOUR (4). THE PATIENT PERFORMED AN ADDITIONAL TEST ON THE SAME DAY WITH A DIFFERENT BRAND (IHEALTH COVID-19 ANTIGEN RAPID TEST) AND TESTED POSITIVE WITH THIS BRAND. THE CONSUMER CONFIRMED THERE WAS NO HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127006 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 192377 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown